NCT00886626

Brief Summary

The prevalence of severely obese children is on the rise. Behavioral therapies for weight loss are successful in some, but others need more aggressive approaches such as drug therapy. In addition, up to 25% of severely obese children have impaired glucose tolerance (IGT), which places them at significantly elevated risk of developing type 2 diabetes mellitus and cardiovascular disease. Although various drug therapies for weight loss and IGT have been explored in adults, few have been evaluated in children. Recently, a new drug class has emerged that targets deficiencies of GLP-1. One of the main glycemic mechanisms of action of the GLP-1 agonists such as exenatide is to enhance glucose disposal in the postprandial setting and improve glucose tolerance. In addition, exenatide can induce weight loss by decreasing appetite and slowing gastric motility.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 23, 2009

Completed
8 days until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

August 17, 2012

Completed
Last Updated

October 29, 2012

Status Verified

October 1, 2012

Enrollment Period

1.8 years

First QC Date

April 22, 2009

Results QC Date

April 25, 2012

Last Update Submit

October 22, 2012

Conditions

Obesity, Morbid

Keywords

ObesityImpaired Glucose ToleranceChildren

Outcome Measures

Primary Outcomes (1)

  • Change in Body Mass Index (BMI)

    Change in body mass index (BMI) over three months

    3-month

Study Arms (2)

Exenatide

EXPERIMENTAL

Exenatide

Drug: Exenatide

Control

NO INTERVENTION

Control - no intervention

Interventions

ExenatideDRUG

Exenatide, subcutaneous injection, 10 mcg, twice per day

Also known as: Byetta
Exenatide

Eligibility Criteria

Age8 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 8-19 years old
  • Subject able to give assent, and parent/guardian capable of giving consent on behalf of the child
  • Body mass index (BMI) ≥ 99th percentile (based on gender and age)

You may not qualify if:

  • Type 1 or 2 diabetes mellitus
  • Initiation of a new drug therapy within the past 30 days prior to the screening visit
  • BMI ≥ 55
  • History of weight loss surgery
  • Obesity from a genetic cause (e.g., Prader-Willi)
  • Central nervous system injury or severe neurological impairment
  • Known systolic or diastolic dysfunction or heart failure
  • Females who are currently pregnant or planning to become pregnant
  • Liver enzymes \> 2.5 times upper limit of normal
  • Severe renal impairment (defined as creatinine clearance \<30 mL/min)
  • Gastrointestinal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

  • Kelly AS, Metzig AM, Rudser KD, Fitch AK, Fox CK, Nathan BM, Deering MM, Schwartz BL, Abuzzahab MJ, Gandrud LM, Moran A, Billington CJ, Schwarzenberg SJ. Exenatide as a weight-loss therapy in extreme pediatric obesity: a randomized, controlled pilot study. Obesity (Silver Spring). 2012 Feb;20(2):364-70. doi: 10.1038/oby.2011.337. Epub 2011 Nov 10.

    PMID: 22076596DERIVED

MeSH Terms

Conditions

Obesity, MorbidObesityGlucose Intolerance

Interventions

Exenatide

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperglycemiaGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological Factors

Limitations and Caveats

Small sample size; un-blinded; crossover study design

Results Point of Contact

Title
Aaron S. Kelly, Ph.D.
Organization
University of Minnesota
kelly105@umn.edu
612-626-3492

Study Officials

  • Aaron S. Kelly, Ph.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2009

First Posted

April 23, 2009

Study Start

May 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

October 29, 2012

Results First Posted

August 17, 2012

Record last verified: 2012-10

Locations

US(1)